According to researchers in Ireland, the reason for cleft palate or cleft lip birth defects is caused by lack of folic acid during the first three months of pregnancy.
The Growing Up in Ireland Study performed by the department of public health and primary care at Trinity College School of Medicine wished to assess the effectiveness of folic acid supplements in preventing cleft palate and cleft lip.
A cleft lip is a separation in the upper lip while a cleft palate is an opening in the roof of the mouth. Clefts result from incomplete development of the lip and/or palate in the early weeks of pregnancy.
According to the study, published in the July issue of the British Journal of General Practice, the rate of cleft lip and palate in infants was 6.8 per one thousand 9-month-olds among women who did not take folic acid, and 1.5 per one thousand 9-month-olds in those who did take folic acid supplements. More than a third of women did not take a folic acid supplement.
Here in the United States, the risk for developing cleft lips and cleft palates in infants of mothers who take Topamax, an anticonvulsant and migraine prevention drug as compared to infants of mothers not taking the anti seizure medication, is double the risk.
There could be other reasons why your child was born with cleft lip or palate but we do know in March 2011, the FDA changed Topamax’ Pregnancy Category from a C to a D, where doctors are cautioned to heavily weigh the risks vs. the benefits because there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. In that case, your doctor would have to expressly communicate these risks.
Topamax has been in the pharmaceutical marketplace since 1994. If your child has a cleft lip or cleft palate and you were prescribed Topamax to prevent seizures or prevent migraine headaches or off label for weight loss, it is suggested that you speak to a Topamax lawyer to find out what your legal options are. Sometimes people may not connect the dots as to cause and effect.